The Outcomes Study

• Research type

  Research Study

• Full title

  The RESPOND Outcomes Study

• IRAS ID

  293270

• Contact name

  Jaime Vera Rojas

• Contact email

  J.Vera@bsms.ac.uk

• Sponsor organisation

  CHIP - Rigshospitalet

• Duration of Study in the UK

  6 years, 0 months, 1 days

• Research summary

  The RESPOND Outcomes study is a research study looking at antiretroviral and other relevant drugs and long-term clinical outcomes in patients living with HIV. Data collected in thisstudy will be used to answer key unanswered questions regarding treatment of people living withHIV.
  Objectives include: monitoring uptake of newer antiretroviral treatment (ART) drugs and drugs for treatment of co-infections and co-morbidities; evaluate safety profiles of the newer ART drugs; investigate long term outcomes and clinical disease progression overall and in specific sub-groups.

  The Outcomes study is a collaboration between investigators from clinics internationally, with a willingness to share data and to use a common follow-up schedule and assessment. Participating sites have a commitment to continue to follow this large cohort that is heterogeneous in both its demographic profile and in ART prescribing patterns thus resulting in enough power to answer many key clinical questions.
  The Outcomes study is a study in the RESPOND International Cohort Consortium of Infectious
  Diseases. RESPOND is an innovative, flexible and dynamic cohort consortium for the study of
  infectious diseases, including HIV, built as a generic structure for facilitating multi stakeholder
  involvement. In RESPOND all collected data is part of a common data repository or ‘data lake’,
  which is stored in a database located at CHIP, Denmark. Datacollection in RESPOND is modular with a core data collection module onto which additional modules/studies can be added. Anonymised patient data can be entered manually via an online secure platform or be electronically transferred from data structures to the data lake.
  In the Outcomes study data will be collected at enrolment and at annual follow-up (FU) visits.
  For patients living with HIV-1 enrolled and under FU, demographic, laboratory, therapeutic and
  clinical data on HIV and viral hepatitis will be collected once a year. Clinical event data (except
  AIDS other than AIDS defining malignancies) will be collected in real-time.

• REC name

  Wales REC 7

• REC reference

  21/WA/0080

• Date of REC Opinion

  3 Mar 2021

• REC opinion

  Favourable Opinion